One of our large pharmaceutical clients is seeking a Compliance Specialist to join their growing team in Malvern, PA. This person will be responsible for supporting audits, authoring nonconformance investigations, corrective and preventative action records, document management, assay trending, root cause problem solving, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and strong written and verbal communication skills.



Other responsibilities include:

-Performs and documents all QC investigations (non-conformance, deviations, invalid assays)

-Authors and executes corrective and preventative action record and execute CAPAs when required for the Quality Control organization

-Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified

-Manages change through chance control process and support internal and external audits

-May performs Gap Assessments for local QC documents against new standards and other quality documents

-Reports data from QC as required for the site management review

-Support Health Authority inspections and provide input to functional laboratory meetings

-Make decisions as a QC representative at cross-functional meetings and provide leadership and insight as a member of global project teams

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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